Clinical trial · Interventional
Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits
Effect of Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits on Colorectal Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pragmatic, randomized, controlled trial of a geographically randomized intervention in which all eligible patients will receive a mailed fecal immunochemical test (FIT) kit (the GeoMail study). In this study, all ZIP Codes in Dallas County will be randomized to either treatment or usual care. Patients in treated neighborhoods will receive kits at the same time; patients in usual care neighborhoods will receive FIT kits randomly throughout the year. All eligible patients will receive a FIT kit each year. The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system. This study represents a pragmatic adaptation to the "FIT first" population health screening strategy in which all eligible patients are mailed FIT kits. All patients will also have access to whatever colorectal cancer (CRC) screening is recommended through usual visit-based care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GeoMail FIT Screening Strategy | Other | — | UNRESOLVED |
| Usual Care FIT Screening Strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care FIT Screening Strategy
- description
- Mailed outreach invitation to complete FIT include: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. Centralized processes to promote guideline-based follow-up.
- interventionNames
- Other: Usual Care FIT Screening Strategy
- type
- EXPERIMENTAL
- label
- GeoMail FIT Screening Strategy
- description
- The experimental arm differs from the active comparator in one way: patients living in treated ZIP codes will receive the mailed outreach at the same time.
- interventionNames
- Other: GeoMail FIT Screening Strategy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Males and females * Age 50-64 years * Seen at least one time at a Parkland primary care clinic within one year prior to randomization * Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance), Medicaid, or private/other insurance * All races and ethnicities Exclusion Criteria: * Up-to-date with CRC screening, defined by: 1. Colonoscopy in the last 10 years 2. Sigmoidoscopy in the last 5 years 3. FIT in the last 11 months * Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps * Address or phone number not on file * Incarcerated
References
Publications (0)
Data not yet available